Facilitating Access to Specialty Treatment
Part of paid clinical trials in Philadelphia, Pennsylvania.
- Sponsor
- Children's Hospital of Philadelphia
- Study ID
- NCT05741411
- Status
- Recruiting
Conditions
- Concussion, Intermediate
- Concussion, Mild
- Concussion, Severe
- Mild Traumatic Brain Injury
Eligibility Criteria
- Sex
- ALL
- Age
- 13 Years - 18 Years
- Healthy Volunteers
- Not accepted
Interventions
- RPM-assisted specialist access — OTHERParticipants will be prompted to report current symptoms and activity once a day via remote patient monitoring chat technology for up to 28 days following injury. Patients with either escalating or plateauing symptoms will be flagged, with an electronic alert sent via the electronic health record to a nurse navigator. The nurse navigator will have access to the symptom data and facilitate scheduling an in person or telehealth specialist visit as indicated. Symptoms will continue to be monitored through the 28-day acute study period with additional clinical visits occurring according to clinical need.
Study Details
The goal of this hybrid implementation-effectiveness study is to evaluate the effectiveness (hastened recovery times) and feasibility (fidelity in connecting to concussion specialty care) of a novel mobile health intervention, designed to reduce disparities in access to specialty care through the use of remote patient monitoring (RPM) to facilitate care hand-off from the emergency department (ED) to concussion specialty care. Participants will report their symptoms and activity once daily through RPM chat technology that is linked to their electronic health record and prompts referral to specialty care.
Key Dates
- Start date
- Mar 11, 2024
- Status verified
- May 2026
- Primary completion
- Mar 31, 2027
- Completion
- Aug 1, 2027
Study Design
- Enrollment
- 210 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- OTHER
Arms
- Experimental: Concussed youth at risk for prolonged symptoms
Primary Outcome Measure
Incidence of Persisting Post-Concussion Symptoms (PPCS, Primary Effectiveness) [ Time Frame: 28 days from injury ]
Central Contacts
- Melissa Godfrey267-425-0386
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 |
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